Transtek Medical Electronics TMB1591BS Blood Pressure Monitor User Manual TMB 1591 FDA

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User Manual
Blood Pressure Monitor
TMB-1591-BS
Arm Type
FCC ID:OU9TMB1591BS
Guangdong Transtek Medical Electronics Co., Ltd.
Zone B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
Thank you very much for selecting TRANSTEK Blood Pressure
Monitor TMB-1591-BS.
To use the monitor correctly and safely, please read the manual
thoroughly.
Please keep this manual well in order to reference in future.
CATALOGUE
CATALOGUE
Table of Contents
INTRODUCTION........................................................................................2
General Description
Safety Information
Indications for Use
Contraindications
Measurement Principle
LCD Display Signal
Monitor Components
BEFORE YOU START................................................................................8
The Choice of Power Supply
Installing and Replacing the Batteries
MEASUREMENT.......................................................................................9
Pairing
Tie the Cuff
Start the Measurement
INFORMATION FOR USER......................................................................14
Tips for measurement
Maintenances
ABOUT BLOOD PRESSURE....................................................................16
What are systolic pressure and diastolic pressure?
What is the standard blood pressure classification?
Irregular heartbeat detector
Why does my blood pressure fluctuate throughout the day?
Why do I get a different blood pressure at home compared to the hospital?
Is the result the same if measuring on the right arm?
TROUBLESHOOTING..............................................................................18
SPECIFICATIONS.....................................................................................19
AUTHORIZED COMPONENT ..................................................................20
CONTACT INFORMATION........................................................................20
FCC STATEMENT......................................................................................21
COMPLIED STANDARDS LIST.................................................................22
EMC GUIDANCE.......................................................................................23
INTRODUCTION
General Description
Thank you for selecting TRANSTEK arm type blood pressure
monitor (TMB-1591-BS). The monitor features blood pressure
measurement, pulse rate measurement and the result storage.
The design provides you with two years of reliable service.
Readings taken by the TMB-1591-BS are equivalent to those
obtained by a trained observer using the cuff and stethoscope
auscultation method.
This manual contains important safety and care information,
and provides step by step instructions for using the product.
Read the manual thoroughly before using the product.
Features:
68mm*90mm Digital LCD display with White backlight
Maximum 99 records
Measuring during inflation technology
INTRODUCTION
Safety Information
The signs below might be in the user manual, labeling or other
component. They are the requirement of standard and using.
Symbol for “THE OPERATION
GUIDE MUST BE READ”
Symbol for “TYPE BF APPLIED
PARTS”
Symbol for “ENVIRONMENT
PROTECTION – Electrical waste
products should not be disposed
of with household waste. Please
followlocal guidelines.”
Caution: These notes must be
observed to prevent any damage
to the device.
SN
Symbol for “MANUFACTURER”
Symbol for “DIRECT CURRENT”
Symbol for “SERIAL NUMBER”
Symbol for “Class II Equipment”
For indoor use only
IP22
F1
T1A/250V Φ3.6*10CCC
The ingress protection: the device
could protected against solid foreign
objects of 12.5mm and greater, and
against vertically falling water drops
when ENCLOSURE tilted up to 15°
Indications for Use
The Transtek Blood Pressure Monitor is digital monitors intended
for use in measuring blood pressure and heartbeat rate with arm
circumference ranging from 22cm to 42cm(about 8¾˝-16½˝).
It is intended for adult indoor use only.
Contraindications
1.The device is not suitable for use on may be pregnant women or
pregnant women.
2.The device is not suitable for use on patients with implanted,electrical
devices,such as cardiac pacemakers, defibrillators.
Measurement Principle
This product uses the Oscillometric Measuring method to
detect blood pressure. Before every measurement, the unit
establishes a “zero pressure” equivalent to the air pressure. Then
it starts inflating the arm cuff, meanwhile, the unit detects pressure
oscillations generated by beat-to-beat pulsatile, which is used to
determine the systolic and diastolic pressure, and also pulse rate.
CAUTION
* Be careful to strangulation due to cables and hoses, particularly due to excessive length.
* At least 30 min required for ME equipment to warm from the minimum storage temperature between
uses until it is ready for intended use. At least 30 min required for ME equipment to cool from the
maximum storage temperature between uses until it is ready for intended use.
* This equipment needs to be installed and put into service in accordance with the information provided in
the ACCOMPANYING DOCUMENTS;
* Wireless communications equipment such as wireless home network devices, mobile phones, cordless
telephones and their base stations, walkie-talkies can affect this equipment and should be kept at least a
distance d away from the equipment. The distance d is calculated by the MANUFACTURER from the 80
MHz to 5.8 GHz column of Table 4 and Table 9 of IEC 60601-1-2:2014, as appropriate.
* Please use ACCESSORIES and detachable partes specified/ authorised by MANUFACTURE.
Otherwise, it may cause damage to the unit or danger to the user/patients.
* There is no luer lock connectors are used in the construction of tubing, there is a possibility that they
might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood
vessel.
* Please use the device under the environment which was provided in the user manual. Otherwise, the
performance and lifetime of the device will be impacted and reduced.
INTRODUCTION
CAUTION
* This device is intended for adult use in homes only.
* The device is not suitable for use on neonatal patients, pregnant women,patients with implanted,
electronical devices, patients with pre-eclampsia, premature ventricular beats, atrial fibrillation, peripheral,
arterial disease and patients undergoing intravascular therapy or arterio-venous shunt or people who
received a mastectomy. Please consult your doctor prior to using the unit if you suffer from illnesses.
* The device is not suitable for measuring the blood pressure of children. Ask your doctor before using it on
older children.
* The device is not intended for patient transport outside a healthcare facility.
* The device is not intended for public use.
* This device is intended for no-invasive measuring and monitoring of arterial blood pressure.
It is not intended for use on extremities other than the arm or for functions other than obtaining a blood
pressure measurement.
* Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do
not begin or end medical treatment without asking a physician for treatment advice.
* If you are taking medication,consult your physician to determine the most appropriate time to measure your
blood pressure. Never change a prescribed medication without consulting your physician.
* Do not take any therapeutic measures on the basis of a self measurement. Never alter the dose of a
medicine prescribed by a doctor. Consult your doctor if you have any question about your blood pressure.
* When the device was used to measure patients who have common arrhythmias such as atrial or ventricular
premature beats or atrial fibrillation, the best result may occur with deviation. Please consult your physician
about the result.
* Don't kink the connection tube during use, otherwise, the cuff pressure may continuously increase which
can prevent blood flow and result in harmful injury to the PATIENT.
* When using this device, please pay attention to the following situation which may interrupt blood flow and
influence blood circulation of the patient, thus cause harmful injury to the patient: connection tubing kinking
too frequent and consecutive multiple measurements; the application of the cuff and its pressurization on any
arm where intravascular access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on
the side of a mastectomy.
* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.
*Do not inflate the cuff on the same limb which other monitoring ME equipment is applied around
simultaneously, because this could cause temporary loss of function of those simultaneously-used monitoring
ME equipment.
*On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff
immediately. Prolonged high pressure (cuff pressure ＞ 300mmHg or constant pressure ＞ 15mmHg for more
than 3 minutes) applied to the arm may lead to an ecchymosis.
*Please check that operation of the device does not result in prolonged impairment of patient blood
circulation.
* When measurement, please avoid compression or restriction of the connection tubing.
* The device cannot be used with HF surgical equipment at the same time.
* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER was clinically
investigated according to the requirements of ISO 81060-2:2013.
* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact the manufacturer.
* This device is contraindicated for any female who may be suspected of, or is pregnant. Besides providing
inaccurate readings, the effects of this device on the fetus are unknown.
* Too frequent and consecutive measurements could cause disturbances in blood circulation and injuries.
* This unit is not suitable for continuous monitoring during medical emergencies or operations.Otherwise, the
patient’s arm and fingers will become anaesthetic, swollen and even purple due to a lack of blood.
* When not in use, store the device with the adapter in a dry room and protect it against extreme moisture,
heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case.
* This device may be used only for the purpose described in this booklet. The manufacturer cannot be held
liable for damage caused by incorrect application.
*This device comprises sensitive components and must be treated with caution. Observe the storage and
operating conditions described in this booklet.
INTRODUCTION
CAUTION
* The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable
anesthetic mixture with air of with oxygen or nitrous oxide.
* Warning: No servicing/maintenance while the ME equipment is in use.
* The patient is an intended operator.
* The patient can measure data and change batteries under normal circumstances and maintain the
device and its accessories according to the user manual.
* To avoid measurement errors, please avoid the condition of strong electromagnetic field radiated
interference signal or electrical fast transient/burst signal.
* The blood pressure monitor, its adaptor, and the cuff are suitable for use within the patient environment.
If you are allergic to polyester, nylon or plastic, please don't use this device.
* During use, the patient will be in contact with the cuff. The materials of the cuff have been tested and
found to comply with requirements of ISO 10993-5:2009 and ISO 10993-10:2010. It will not cause any
potential sensization or irritation reaction.
* Adaptor is specified as a part of ME EQUIPMENT.
* If you experience discomfort during a measurement, such as pain in the arm or other complaints, press
the START/STOP button to release the air immediately from the cuff. Loosen the cuff and remove it from
your arm.
* If the cuff pressure reaches 40 kPa (300 mmHg), the unit will automatically deflate. Should the cuff not
deflate when pressures reaches 40 kPa (300 mmHg), detach the cuff from the arm and press the
START/STOP button to stop inflation.
* Before use, make sure the device functions safely and is in proper working condition. Check the device,
do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause
injury, improper results, or serious danger.
* Do not wash the cuff in a washing machine or dishwasher!
* The service life of the cuff may vary by the frequency of washing, skin condition, and storage state. The
typical service life is 10000 times.
* It is recommended that the performance should be checked every 2 years and after maintenance and
repair, by retesting at least the requirements in limits of the error of the cuff pressure indication and air
leakage (testing at least at 50mmHg and 200mmHg).
* Please dispose of ACCESSORIES, detachable parts, and the ME EQUIPMENT according to the local
guidelines.
* Manufacturer will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions,etc., to assist to service personnel in parts repair.
* The plug/adapter plug pins insulates the device from the main supply. Do not position the device in a
position where it is difficult to disconnect from the supply mains to safely terminate operation of ME
equipment.
* The operator shall not touch output of batteries /adapter and the patient simultaneously.
* Cleaning :Dust environment may affect the performance of the unit. Please use the soft cloth to clean
the whole unit before and after use. Don’t use any abrasive or volatile cleaners.
* The device doesn’t need to be calibrated within two years of reliable service.
* If you have any problems with this device, such as setting up, maintaining or using, please contact the
SERVICE PERSONNEL of Transtek. Don’t open or repair the device by yourself in the event of
malfunctions. The device must only be serviced, repaired and opened by individuals at authorized
sales/service centers.
* Please report to Transtek if any unexpected operation or events occur.
* Keep the unit out of reach of infants, young children or pets to avoid inhalation or swallowing of small
parts. It is dangerous or even fatal.
INTRODUCTION
INTRODUCTION
LCD Display Signal
Monitor Components
CUFF
SYS
mmHg
AIR HOSE
DIA
mmHg
PULSE
/MIN
SYMBOL
DESCRIPTION
LCD DISPLAY
EXPLANATION
Systolic blood pressure
High pressure result
Diastolic blood pressure
Low pressure result
Pulse
Pulse/minute
mmHg
Measurement Unit of the blood pressure
Irregular heartbeat
Irregular heartbeat detection
Battery Indicator
Indicate the current battery
List
Grade
The grade of the blood pressure
1. Blood Pressure Monitor 2. Cuff (about 22cm~42cm)
(TMB-1591-BS)
(Type BF applied part)
Shocking reminder
AIR CONNECTOR PLUG
ON/STANDBY BUTTON
Component list of
pressure measuring system
1 Cuff
2 Air pipe
3 PCBA
4 Pump
5 Valve
DC POWER SOCKET
BATTERY COMPARTMENT
Shocking will result in inaccurate
Data transmission error
Data transmission error
Heartbeat
Heartbeat dectetion during measurement
3. 4*AA alkaline batteries
4. User manual
5. AC adaptor (UE08WCP-060100SPA)
BEFORE YOU START
MEASUREMENT
The Choice of Power Supply
1.Battery powered mode:
6VDC 4*AA alkaline batteries
2.AC adaptor powered mode:
6V
1A
(Can be supplied by AC adaptor model
UE08WCP-060100SPA !)
Right picture is the hole in for
power adaptor.
Pairing
Turn on Bluetooth and APP. Make sure both are ON when pairing is
proceeding.
When the blood pressure monitor is off, press On/Standby button for
2 full seconds to enter bluetooth pairing mode. The symbol
flashes, indicating the pairing is proceeding.
CAUTION
In order to get the best effect and protect your monitor,please use the right
battery and special power adaptor. The power adapter is a part of the device.
After using, please pull out the adaptor plug insulates from the main supply.
Do not position the device in a position where it is difficult to disconnect from
the supply mains.
Installing and Replacing the Batteries
1.Slide off the battery cover.
2.Install the batteries by
matching the correct polarity,
as shown.
3.Replace the cover.
Replace the batteries whenever the below happen
The
shows
The display dims
The display does not light up
CAUTION
Remove batteries if the device is not likely to be used for some time.
The old batteries are harmful to the environment, do not dispose with other
daily trash.
Then please select the user ID you want to connect with your
smartphone on the app to continute the pair-up.
If succeed, symbol
will turn off.
If fail, symbol
turns off.
will be shown. Then blood pressure monitor
will flash all the time until the blood pressure
Bluetooth Module No.: AW51802
RF Frequency Range: 2402 MHz to 2480 MHz
Max Power: -0.43dbm
Supply Voltage: 2V-3.6 V
Transmitting Distance: 10 meters
Remove the old batteries from the device and follow your local recycling
guidelines.
MEASUREMENT
MEASUREMENT
Tie the Cuff
Start Measurement
When the blood pressure monitor is off, press On/Standby button to
turn it on, it will finish the whole measurement.
1.Tie the cuff on your upper arm,
then position the tube off-center
toward the inner side of arm in
line with the little finger.
LCD display
Adjust to zero.
2.The cuff should be snug but not
too tight. You should be able to
insert one finger between the
cuff and your arm.
3.Sit comfortably with your arm
resting on a flat surface.
4.Correct position:
- Bare your arm or wear tights only
when starting measurement.
- Sit comfortably with legs
uncrossed, feet flat on the floor,
back and arm supported.
The center of the cuff should be at
the same level as the right atrium
of the heart.
2~3cm
Inflating and Measuring
Display and save the result.
Rest for 5 minutes before
measuring.
Wait at least 3 minutes between
measurements. This allows your
blood circulation to recover.
For a meaningful comparison,
try to measure under similar
conditions. For example, take daily
measurements at approximately
the same time, on the same upper
arm, or as directed by a physician.
10
11
MEASUREMENT
MEASUREMENT
The blood pressure monitor will proceed to data transmission after
measurement. The bluetooth symbol flashes on the LCD indicates
data is transmitting.
After successful transfer, the device powers off the Bluetooth
radio and the icon (and rectangle) are removed.
If the user presses and releases the On/Standby button, another
reading is initiated.
If the user presses and holds the On/Standby button for 2
seconds, the device powers down.
Or if there is no operation, after a 10 seconds of inactivity, the
device powers down.
Notes: During inflation, the heart icon in the upper left blinks in
accordance with the user’s pulse rate.
Additionally, during inflation the progress metre to the right of
the digits builds vertically up as the pressure increases
according to the table below.
Segments
12
Pressure
Segments
Pressure
>= 0
>= 140
>= 40
>= 160
>= 80
>= 180
>= 120
>= 200
During the measurement, if you press the On/Standby button to stop
the measurement, the numerics are cleared. It will display as below:
If you press and release the On/Standby button, another reading is
initiated.
If you press and hold the On/Standby button for 2 seconds, the
device powers down.
Or if there is no operation, after a 10 seconds of inactivity, the device
powers down.
CAUTION
The most recent record (1) is shown first. Each new
measurement is assigned to the first (1) record. All
other records are pushed back one digit (e.g., 2
becomes 3, and so on), and the oldest record (99) is
dropped from the list.
13
INFORMATION FOR USER
INFORMATION FOR USER
Tips for Measurement
Maintenance
Measurements may be inaccurate if taken in the
following circumstances.
wait at least 1 hour after dinner
or drinking
14
Immediate measurement
after tea, coffee, smoking
In order to get the best performance, please follow the
instructions below.
Put in a dry place and avoid the
sunshine
Avoid touching water,
clean it with a dry cloth in case.
Wait at least 20 minutes after
taking a bath
When talking or moving your fingers
Avoid intense shaking
and collisions
Avoid dusty and unstable
temperature environment
In a very cold environment
When you want to discharge urine
Using wet cloths to remove dirt
Avoid washing the cuff
15
ABOUT BLOOD PRESSURE
ABOUT BLOOD PRESSURE
What are systolic pressure and diastolic
pressure?
When ventricles contract and pump blood
out of the heart, the blood pressure
reaches its maximum value in the cycle,
which is called systolic pressure. When
the ventricles relax, the blood pressure
reaches its minimum value in the cycle,
which is called diastolic pressure.
Systolic
Diastolic
press
relax
blood discharging
artery
blood entering
vein
What is the standard blood pressure classification?
The chart on the right is the
standard blood pressure classification published by American
Heart Association (AHA).
This chart reflects blood pressure categories defined by American Heart Association.
Blood Pressure Category
Systolic
mmHg (upper#)
Diastolic
mmHg (lower#)
less than 120
and
less than 80
Elevated
120-129
and
less than 80
High Blood Pressure
(Hypertension) Stage 1
130-139
or
80-89
140 or higher
or
90 or higher
Normal
High Blood Pressure
(Hypertension) Stage 2
Hypertensive Crisis
(Consult your doctor immediately) Higher than 180
and/or
Higher than 120
CAUTION
Please consult a physician if your measuring result falls outside the range.
Please note that only a physician can tell whether your blood pressure value
has reached a dangerous point.
Irregular Heartbeat Detector
An irregular heartbeat is detected when a heartbeat rhythm varies while the unit is measuring
the systolic and diastolic blood pressure.During each measurement, the monitor records all the
pulse intervals and calculate the average ; if there are two or more pulse intervals ,the difference
between each interval and the average is more than the average value of ±25% , or there are four
or more pulse intervals ,the difference between each interval and the average is more than the
average value of ±15%,the irregular heartbeat symbol appears on the display when the
measurement results are appear.
CAUTION
The appearance of the IHB icon indicates that a pulse irregularity consistent
with an irregular heartbeat was detected during measurement. Usually this is
NOT a cause for concern. However, if the symbol appears often, we
recommend you seek medical advice. Please note that the device does not
replace a cardiac examination, but serves to detect pulse irregularities at an
early stage.
16
Why does my blood
pressure fluctuate
throughout the day?
1. Individual blood pressure
varies multiple times everyday. It
is also affected by the way you tie
your cuff and your measurement
position, so please take the
measurement under the same
conditions.
2.If the person takes medicine,
the pressure will vary more.
3.Wait at least 3 minutes for
another measurement.
Why do I get a different
blood pressure at home
compared to the
hospital?
The blood pressure is
different even throughout the
day due to weather, emotion,
exercise etc, Also, there is the
“white coat” effect, which means
blood pressure usually
increases in clinical settings.
What you need to pay
attention to when you
measure your blood
pressure at home:
If the cuff is tied properly.
If the cuff is too tight or too
loose.
If the cuff is tied on the upper
arm.
If you feel anxious.
Taking 2-3 deep breaths
before beginning will be better for
measuring.
Advice: Relax yourself for 4-5
minutes until you calm down.
Is the result the same if
measuring on the right
arm?
It is ok for both arms, but
there will be some different
results for different people. We
suggest you measure the same
arm every time.
17
TROUBLESHOOTING
SPECIFICATIONS
This section includes a list of error messages and
frequently asked questions for problems you may
encounter with your blood pressure monitor. If the
products not operating as you think it should, check here
before arranging for servicing.
PROBLEM SYMPTOM
No power
Low
batteries
Error
message
Display
will not light up.
shows
“out ” shows
REMEDY
Display mode
Measurement mode
Measurement range
Batteries are exhausted. Replace with new batteries
Batteries are inserted
incorrectly.
Insert the batteries
correctly
AC adaptor is inserted
incorrectly.
Insert the AC adaptor
tightly
The display
indicates the
Batteries are low.
“BAT LO”
message, pauses
for 3 seconds.
The battery icon
shows empty
(does not flash.)
E 1 shows
Warning
message
CHECK THIS
Power supply
Unsuccessful pairing.
The cuff is not secure.
Out of measurement
range
Accuracy
Replace with new batteries
Readjust the cuff and
relax for a moment
and then measure again.
Relax for a moment.
Refasten the cuff and then
measure again. If the
problem persists, contact
your physician.
A temperature range of :+5°C to +40°C
A relative humidity range of 15% to 90%,
non-condensing, but not requiring a water
vapour partial pressure greater than 50 hPa
An atmospheric pressure range of :
700 hPa to 1060 hPa
Storage & transportation
condition
Measurement perimeter
of the upper arm
Net Weight
External dimensions
Attachment
Temperature:-20°C to +60°C
A relative humidity range of ≤ 93%, non-condensing,
at a water vapour pressure up to 50hPa
About 22cm~42cm
Approx.300g(Excluding the dry cells)
Approx.92mm*140mm*46mm
4*AA alkaline batteries,user manual,AC adapter
Mode of operation
Continuous operation
Degree of protection
Type BF applied part
Protection against
ingress of water
Software Version
18
1A
(Can be supplied by AC adaptor model
UE08WCP-060100SPA !)
Digital LCD V.A.68mm*90mm
Oscillographic testing mode
Rated cuff pressure:
0mmHg~299mmHg(0kPa ~ 39.9kPa)
Measurement pressure:
SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa)
DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa)
Pulse value: (40-199)beat/minute
Pressure:
5℃-40℃ within±3mmHg
pulse value:±5%
Normal working condition
Check if both the APP and
Bluetooth are on, operate
and send the data again.
Battery powered mode:
6VDC 4*AA alkaline batteries
AC adaptor powered mode:6V
IP22
V01
WARNING: No modification of this equipment is allowed.
19
FCC STATEMENT
AUTHORIZED COMPONENT
Authorized Component
1.please use the TRANSTEK
authorized adapter.
Adapter
Type： UE08WCP-060100SPA
Input：100~240V，50~60Hz,400mA
Output：6V
1A
( Conforms to UL certificate )
Contact Information
For more information about our products, please visit www.transtek.cn.you
can get customer service, usual problems and customer download, transtek
will serve you anytime.
FCC Statement
FCC ID:OU9TMB1591BS
This device complies with Part 15 of the FCC Rules. Operation is subject
to the following two conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
Caution: The user is cautioned that changes or modifications not
expressly approved by the party responsible for compliance could void
the user's authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the
limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
These limits are designed to provide reasonable protection against
harmful interference in a residential installation. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to
radio communications. However, there is no guarantee that interference will
not occur in a particular installation.
If this equipment does cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one or more
of the following measures:
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment and receiver.
-- Connect the equipment into an outlet on a circuit different from that to
which the receiver is connected.
-- Consult the dealer or an experienced radio/TV technician for help.
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure limits set forth for
an uncontrolled environment.
This transmitter must not be co-located or operating in conjunction with
any other antenna or transmitter.
Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd.
Company: Guangdong Transtek Medical Electronics Co., Ltd.
Address: Zone B, No.105 ,Dongli Road, Torch Development District,
Zhongshan,528437,Guangdong,China
20
21
COMPLIED STANDARDS LIST
Complied Standards List
Risk management
Labeling
User manual
General Requirements
for Safety
EN ISO 14971:2012 / ISO 14971:2007 Medical devices Application of risk management to medical devices
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices.
Symbols to be used with medical device labels, labelling and
information to be supplied. Part 1 : General requirements
EN 1041:2008 Information supplied by the manufacturer of medical
devices
EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical
electrical equipment - Part 1: General requirements for basic safety
and essential performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical
equipment - Part 1-11: General requirements for basic safety and
essential performance - Collateral standard: Requirements for medical
electrical equipment and medical electrical systems used in the home
healthcare environment
Electromagnetic
compatibility
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical
equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral standard: Electromagnetic
disturbances - Requirements and tests
Performance
requirements
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1:
Requirements and test methods for non-automated measurement type
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers Part 3: Supplementary requirements for electro-mechanical blood
pressure measuring systems
IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part
2-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers
Clinical investigation
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test
procedures to determine the overall system accuracy of automated
non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2:
Clinical validation of automated measurement type
Usability
Software life-cycle
processes
Bio-compatibility
22
EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013
Medical electrical equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral standard: Usability
IEC 62366-1:2015 Medical devices - Part 1: Application of
usability engineering to medical devices
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical
device software - Software life-cycle processes
EMC GUIDANCE
EMC Guidance
1)This product needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided,
and this unit can be affected by portable and mobile RF communications
equipment.
2)* Do not use a mobile phone or other devices that emit electromagnetic
fields, near the unit. This may result in incorrect operation of the unit.
3)Caution: This unit has been thoroughly tested and inspected to assure
proper performance and operation!
4)* Caution: This machine should not be used adjacent to or stacked with
other equipment and that if adjacent or stacked use is necessary, this
machine should be observed to verify normal operation in the configuration in
which it will be used.
Table 1
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Compliance
Group 1
Class B
Electromagnetic environment - guidance
The device uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in nearby
electronic equipment.
The device is suitable for use in all establishments,
other than domestic and those directly connected to
the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
ISO 10993-1:2009 Biological evaluation of medical devices- Part
1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
23
EMC GUIDANCE
EMC GUIDANCE
Table 2
Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
Electrical fast
transient/burst
IEC 61000-4-4
power supply lines:
±2 kV
Surge
IEC61000-4-5
line(s) to line(s): ±1 kV
line(s) to earth: ±2 kV
100 kHz repetition
frequency
Voltage dips,
short interruptions
and voltage
variations on
power supply
input lines
Compliance level
±8 kV contact
±15 kV air
power supply lines:
±2 kV
input/output lines:
±1 kV
0%UT; 0.5 cycle
At 0°, 45°, 90°, 135°,
180°,225°,270° and 315°
0%UT ; 1 cycle
and
70%UT ; 25/30 cycles
Single phase: at 0°
0% UT ; 300 cycle
IEC 61000-4-11
Electromagnetic
environment - guidance
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Mains power quality should be
that of a typical commercial or
hospital environment.
line(s) to line(s): ±1 kV Mains power quality should be
that of a typical commercial or
hospital environment.
100 kHz repetition
frequency
0% UT ; 0.5 cycle
Mains power quality should be
At 0°, 45°, 90°, 135°, that of a typical commercial or
180°,225°,270° and
hospital environment.
315°
0% UT ; 1 cycle
and
70% UT ; 25/30 cycles
Single phase: at 0°
0% UT ;300 cycle
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device should assure that it is used in such an environment.
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
IEC 60601
Test level
150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at 1kHz
10V/m, 80% Am
at 1kHz
Compliance
level
150 kHz to
80 MHz:
3 Vrms
6Vrms (in ISM
and amateur
radio bands)
80% Am at 1kHz
10V/m, 80% Am
at 1kHz
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the device, including cables, than the
recommended separation distance calculated
from the equation appropriate for the frequency
of the transmitter.
Recommended separation distances:
d=0.35 P ;
d=1.2 P
80 MHz to 800 MHz: where, P is the maximum
output power rating of the
d=1.2 P
800 MHz to 2.7 GHz: transmitter in watts (W)
according to the
d=2.3 P
transmitter manufacturer,
d is the recommended
separation distance in
meters (m). Field
strengths from fixed RF
transmitters, as
determined by an
electromagnetic site
survey, should be less
than the compliance level
in each frequency range.
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
NOTE 1
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
Power frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
NOTE
24
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
UT is the a.c. mains voltage prior to application of the test level.
a Field strengths from fixed transmitters, such as base stations for radio (cellular / cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the device is used exceeds the applicable RF compliance level
above, the device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
25
EMC GUIDANCE
EMC GUIDANCE
Table 5
Table 4
Recommended separation distances between portable and mobile RF communications
equipment and the device.
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the device can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmittters) and the device as recommended below, according to the maximum output power of the
communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d = 3.5 P
80 MHz to 800 MHz
800 MHz to 2.7 GHz
d = 1.2 P
d = 2.3 P
0.12
0.23
Guidance and manufacturer’s declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the
user of the device, should assure that it is used in such an environment.
Radiated RF Test
Band a) Service a) Modulation b) Modulation b)
IEC61000-4-3 Frequency (MHz)
(W)
(Test
(MHz)
specifications
1.8
for
385
380-390 TETRA
Pulse
ENCLOSURE
400
modulation b)
PORT
18Hz
IMMUNITY to
GMRS 460，FM c) ± 5kHz
RF wireless
deviation 1kHz
450
380-390 FRS 460
communicatio
sine
ns equipment)
710
704-787 LTE Band Pulse
0.2
modulation b)
13,
745
217Hz
17
780
0.01
0.12
0.1
0.37
0.38
0.73
810
1.2
1.2
2.3
870
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in metres (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
800-960
GSM
Pulse
800/900,
modulation b)
TETRA 800, 18Hz
iDEN 820,
CDMA 850,
LTE Band 5
17001990
GSM 1800; Pulse
CDMA 1900; modulation b)
GSM 1900; 217Hz
DECT;
LTE Band 1,
3,
4,25; UMTS
930
1720
1845
1970
2450
24002570
5240
51005800
5240
Bluetooth, Pulse
modulation b)
WLAN,
217 Hz
802.11
b/g/n, RFID
2450, LTE
Band 7
WLAN
802.11
a/n
Pulse
modulation b)
217 Hz
Distance (m) IMMUNITY
TEST
LEVEL
(V/m)
0.3
27
0.3
28
0.3
0.3
28
0.3
28
0.3
28
0.2
0.3
5785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna
and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by
IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does
not represent actual modulation, it would be worst case.
The MANUFACTURER should consider reducing the minimum separation distance, based on RISK
MANAGEMENT, and using higher IMMUNITY TEST LEVELS that are appropriate for the reduced
minimum separation distance. Minimum separation distances for higher IMMUNITY TEST LEVELS shall be
calculated using the following equation:
E=
Where P is the maximum power in W, d is the minimum separation distance in m, and E is the IMMUNITY
TEST LEVEL in V/m.
26
27

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Swatch Colorant Cyan            : 0.000000, 0.000000, 0.000000, 6.250000, 62.500000, 51.562500, 87.890601, 26.953101, 16.796899, 0.390601, 0.000000, 0.000000, 0.000000, 4.687500, 18.750000, 50.000000, 74.218798, 85.937500, 89.843798, 75.781298, 78.125000, 69.531298, 87.109399, 98.828101, 100.000000, 74.218798, 49.218798, 34.765601, 11.718798, 0.000000, 22.656298, 39.843798, 50.390601, 57.421899, 22.656298, 31.640601, 35.937500, 39.062500, 41.406298, 47.656298, 14.000000, 20.000000, 0.000000, 20.000000, 0.000000, 0.000000, 10.000000, 0.000000, 0.000000, 100.000000, 20.000000, 40.000001, 0.000000, 61.000001, 31.999999, 41.000000, 0.000000, 63.000000, 2.000000, 28.999999, 74.000001, 100.000000, 7.000000, 3.000000, 0.000000, 69.999999, 0.000000, 3.000000, 5.000000, 26.999998, 0.000000, 1.000000, 2.000000, 26.999998, 87.000000, 5.000000, 64.999998, 0.000000, 75.020999, 100.000000, 100.000000, 92.971700, 11.000100, 61.327499, 92.971700, 92.352200, 0.003100, 25.384900, 69.997698, 35.000598, 100.000000, 94.000202, 58.000201, 38.000500, 74.609399, 72.265601, 69.140601, 65.234399, 59.375000, 51.562500, 42.578101, 30.468798, 19.140601, 8.593798, 3.515601, 15.234399, 65.234399, 82.421899, 48.046899
Swatch Colorant Magenta         : 0.000000, 0.000000, 98.828101, 0.000000, 0.000000, 0.000000, 76.562500, 81.250000, 97.656298, 98.828101, 79.296899, 50.000000, 34.765601, 0.000000, 0.000000, 0.000000, 0.000000, 17.578101, 33.203101, 0.000000, 8.984399, 14.843798, 52.343798, 96.093798, 100.000000, 98.046899, 98.828101, 100.000000, 100.000000, 96.484399, 27.343798, 42.578101, 52.734399, 60.156298, 38.281298, 48.828101, 57.031298, 63.671899, 69.531298, 73.046899, 0.000000, 0.000000, 20.000000, 0.000000, 0.000000, 0.000000, 0.000000, 10.000000, 0.000000, 0.000000, 100.000000, 0.000000, 100.000000, 19.000000, 51.999998, 0.000000, 61.000001, 83.999997, 77.999997, 0.000000, 57.999998, 100.000000, 40.000001, 7.000000, 0.000000, 10.000000, 0.000000, 30.000001, 7.000000, 25.000000, 16.000000, 5.000000, 50.999999, 0.000000, 74.000001, 42.999998, 30.000001, 82.999998, 67.968297, 60.000002, 72.999603, 87.972802, 0.999500, 0.003100, 87.972802, 74.676102, 96.020401, 45.477998, 0.003100, 0.000000, 72.000098, 0.000000, 16.999801, 3.999300, 67.578101, 66.406298, 62.890601, 57.812500, 51.171899, 42.968798, 34.765601, 24.218798, 14.843798, 6.250000, 2.343798, 44.140601, 32.812500, 70.703101, 78.906298
Swatch Colorant Yellow          : 0.000000, 0.000000, 100.000000, 96.093798, 100.000000, 12.500000, 0.000000, 0.000000, 92.187500, 96.875000, 96.484399, 98.046899, 86.718798, 92.968798, 97.656298, 98.828101, 99.218798, 100.000000, 98.437500, 74.609399, 45.703101, 0.000000, 0.000000, 3.515601, 26.171899, 0.781298, 1.171899, 37.109399, 49.218798, 20.312500, 39.843798, 52.343798, 60.546899, 63.671899, 63.281298, 73.828101, 83.593798, 92.968798, 96.484399, 83.203101, 0.000000, 40.000001, 20.000000, 20.000000, 0.000000, 0.000000, 20.000000, 10.000000, 0.000000, 0.000000, 80.000001, 0.000000, 100.000000, 71.999997, 0.000000, 71.999997, 34.000000, 0.000000, 42.999998, 22.999999, 0.000000, 0.000000, 63.000000, 13.000000, 0.000000, 5.000000, 0.000000, 30.000001, 22.999999, 22.999999, 64.999998, 16.000000, 16.000000, 20.000000, 0.000000, 47.000000, 41.000000, 42.999998, 67.022198, 0.000000, 0.000000, 89.019603, 0.000000, 100.000000, 89.019603, 0.003100, 94.604397, 62.374300, 94.830197, 60.000598, 0.000000, 100.000000, 0.000000, 0.000000, 66.796899, 64.843798, 61.718798, 56.640601, 50.390601, 42.968798, 35.156298, 24.609399, 15.625000, 6.640601, 2.343798, 85.546899, 0.000000, 0.000000, 0.000000
Swatch Colorant Black           : 0.000000, 100.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 6.640601, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 3.906298, 25.781298, 0.000000, 0.000000, 0.000000, 0.000000, 0.390601, 24.609399, 0.390601, 0.000000, 10.937500, 0.781298, 0.000000, 0.000000, 6.640601, 23.437500, 41.796899, 1.171899, 9.765601, 22.656298, 35.546899, 48.828101, 67.968798, 0.000000, 20.000000, 0.000000, 0.000000, 0.000000, 100.000000, 0.000000, 0.000000, 69.999999, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 100.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 0.000000, 20.999999, 0.000000, 90.164000, 6.000000, 2.000400, 79.998499, 63.999897, 0.003100, 79.998499, 0.003100, 0.003100, 0.003100, 0.003100, 0.000000, 32.000700, 0.000000, 46.000701, 19.000199, 89.843798, 77.734399, 58.203101, 36.328101, 19.921899, 7.421899, 1.171899, 0.000000, 0.000000, 0.000000, 0.000000, 0.781298, 0.000000, 0.000000, 0.000000
Swatch Colorant Tint            : 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000, 100.000000
Producer                        : Adobe PDF library 9.90
Page Count                      : 15
Author                          : Shuting
Keywords                        : GBF-1251-B
Subject                         : User Manual

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